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Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus

NCT03648437 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-10-18

No results posted yet for this study

Summary

The purpose of this pilot trial is to study efficacy and safety of simultaneous intravenous (iv) ibuprofen/indomethacin and paracetamol medications in the closure of patent ductus arteriosus (PDA) in preterm infants. It is randomized, placebo-controlled, double-blind, phase 1, multicenter, clinical trial.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Paracetamol 10Mg/mL

Experimental drug

DRUG

0.45% Sodium Chloride

Placebo comparator

DRUG

Ibuprofen

Standard therapy

DRUG

Indomethacin

Standard therapy

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Turku University Hospital

    collaborator OTHER_GOV

  • University of Oulu

    lead OTHER

Principal Investigators

  • Outi Aikio, MD, PhD · Oulu Univerisity Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2024-10-04
Completion
2024-10-04

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03648437 on ClinicalTrials.gov